1. Field of the Invention
The present invention relates in general to a method for treating bladder cancer (e.g., urothelial carcinoma, transitional cell carcinoma, papillary carcinoma, flat carcinoma, squamous cell carcinoma, adenocarcinoma, small cell carcinoma, sarcoma, etcetera) and, more particularly, to a method for treating a plurality of forms of bladder cancer including, but not limited to, cancer arising from the epithelial lining of the urinary tract.
2. Background Art
Bladder cancer, also known as urothelial carcinoma (transitional cell carcinoma), is a type of cancer that is found in the lining of the urinary tract including the pelvis, ureters, bladder, and parts of the urethra. The most common form of bladder cancer is urothelial carcinoma. Bladder cancer occurs in people of all races and can affect people of any age. Bladder cancer is the fourth most common type of cancer in men and the ninth most common cancer in women. Bladder cancer is responsible for approximately 170,000 deaths per year in the United States.
While doctors do not know the exact cause of bladder cancer, tobacco is believed to be the main known contributor. Occupational exposure in the workplace to carcinogens such as benzidine (i.e., aromatic amines) can also result in bladder tumors. Occupations at risk for exposure to bezidine are bus drivers, rubber workers, motor mechanics, leather workers, blacksmiths, machine setters, mechanics, and hairdressers—because of the frequent exposure to permanent hair dyes. One other modifiable factor that is less strongly associated with bladder cancer, is obesity.
Bladder cancer or urothelial carcinoma is often described based on how far they have invaded the wall of the bladder. Papillary carcinomas, or non-invasive bladder cancer, grow in slender, finger-like projections from the inner surface of the bladder toward the hollow center. Papillary tumors often grow toward the center of the bladder without growing into the deeper bladder layers. Low-grade (slow growing), non-invasive papillary cancer tends to have a good outcome. Flat carcinomas are another example of non-invasive bladder cancer. Flat carcinomas do not grow toward the hollow part of the bladder. If either a papillary or flat tumor grows into deeper layers of the bladder, it is called an invasive urothelial carcinoma. Invasive bladder cancers are more likely to spread and are much harder to treat.
Other cancers that can start in the bladder are squamous cell carcinoma, adenocarcinoma, small cell carcinoma, and sarcoma.
To the best of Applicant's knowledge, the current treatment of bladder cancer involves invasive surgery, radical cystectomy, intravesical therapy, chemotherapy, radiation therapy and/or immunotherapy. However, these treatments are replete with drawbacks such as flu-like symptoms, extreme fatigue, hair-loss, DNA damage, development of secondary cancer, cell migration into the bloodstream, and complications from surgery.
Alternative methods for treating bladder cancer have been known in the art for years and are the subject of a plurality of patents and/or publications, including, for example: U.S. Pat. No. 9,486,434 entitled “Method for Delivery and Use of Isothiocyanates for Prophylaxis and/or Therapy of Bladder Cancer,” U.S. Pat. No. 7,326,734 entitled “Treatment of Bladder and Urinary Tract Cancers,” U.S. Pat. No. 7,268,120 entitled “Methods for Treating Cancer Using Cytokine-Expressing Polynucleotides,” U.S. Pat. No. 6,833,438 entitled “Serpentine Transmembrane Antigens Expressed in Human Cancers and Uses Thereof,” U.S. Pat. No. 5,690,928 entitled “Method of Treating Bladder Cancer Cells,” U.S. Pat. No. 5,301,688 entitled “Method for Localisation and Therapy of Occult Bladder Cancer,” U.S. Patent Application Publication No. 2014/0056986 entitled “Methods of Treating Bladder Cancer,” U.S. Patent Application Publication No. 2008/0119440 entitled “Combination with Bis(Thiohydrazide Amides) for Treating Cancer,” U.S. Patent Application Publication No. 2008/0064047 entitled “Methods for Diagnosis and Prognosis of Epithelial Cancers,” U.S. Patent Application Publication No. 2007/0161580 entitled “Anti-Tumor Compounds with Angeloyl Groups,” U.S. Patent Application Publication No. 2005/0276872 entitled “Composition Comprising Xanthoceras Sorbifolia Extracts, Compounds Isolated from Same, Methods for Preparing Same and Uses Thereof,” U.S. Patent Application Publication No. 2004/0253265 entitled “Biological Compositions and Methods for Treatment of Bladder Cancer,” and U.S. Patent Application Publication No. 2002/0123465 entitled “TGF-ALPHA Polypeptides, Functional Fragments and Methods of Use Therefor,” all of which are hereby incorporated herein by reference in their entirety—including all references cited therein.
U.S. Pat. No. 9,486,434 appears to disclose a composition that contains a mixture of broccoli seed and mustard seed. Before mixing the broccoli seed with the mustard seed, the broccoli seed is subjected to baking and a pressurized heat treatment. The broccoli seed is baked at a temperature of at least 200 degrees Fahrenheit for at least 60 minutes, and is subjected to a pressurized heat treatment of at least 200 degrees Fahrenheit at a pressure of at least 10 pounds/square inch for at least 5 minutes. Also provided is a method for therapy and/or prophylaxis of bladder cancer in an individual. The method entails administering orally to the individual a composition that contains an isothiocyanate (ITC) or a derivative thereof such that the administration inhibits the growth and/or recurrence of bladder cancer. Nutraceutical compositions are also provided.
U.S. Pat. No. 7,326,734 appears to disclose compositions of matter and methods wherein chalcone (an aromatic ketone) and flavone derivatives are administered to human or veterinary patients for the treatment of bladder or urinary tract cancer. One specific compound disclosed in the '734 patent includes 2′-hydroxy-4,4′,6′-trimethoxychalcone.
U.S. Pat. No. 7,268,120 appears to disclose a pharmaceutical composition, comprising a non-infectious, non-integrating polynucleotide construct comprising a polynucleotide encoding an interferon w and one or more cationic compounds. The '120 patent also discloses methods of treating cancer in a mammal, comprising administering into a muscle of the mammal a non-infectious, non-integrating DNA polynucleotide construct comprising a polynucleotide encoding a cytokine. In addition, the '120 patent discloses methodologies for selective transfection of malignant cells with polynucleotides expressing therapeutic or prophylactic molecules in intra-cavity tumor bearing mammals. More specifically, the '120 patent provides a methodology for the suppression of an intra-cavity dissemination of malignant cells, such as intraperitoneal dissemination. Furthermore, the '120 patent discloses compositions and methods to deliver polynucleotides encoding polypeptides to vertebrate cells in vivo, where the composition comprises an aqueous solution of sodium phosphate.
U.S. Pat. No. 6,833,438 appears to disclose a family of cell surface serpentine transmembrane antigens. Two of the proteins in this family are exclusively or predominantly expressed in the prostate, as well as in prostate cancer, and thus members of this family have been termed “STEAP” (Six Transmembrane Epithelial Antigen of the Prostate). Four particular human STEAPs are described and characterized in the '438 patent. The human STEAPs exhibit a high degree of structural conservation among them but show no significant structural homology to any known human proteins. The prototype member of the STEAP family, STEAP-1, appears to be a type IIIa membrane protein expressed predominantly in prostate cells in normal human tissues. Structurally, STEAP-1 is a 339 amino acid protein characterized by a molecular topology of six transmembrane domains and intracellular N- and C-termini, suggesting that it folds in a “serpentine” manner into three extracellular and two intracellular loops. STEAP-1 protein expression is maintained at high levels across various stages of prostate cancer. Moreover, STEAP-1 is highly over-expressed in certain other human cancers.
U.S. Pat. No. 5,690,928 appears to disclose methods and compositions for treating bladder cancer using TGF-alpha or EGF fused to PE40 or cysteine modified derivatives. The '928 patent also discloses a method of producing TGF-alpha-PE40 derivatives of enhanced potency.
U.S. Pat. No. 5,301,688 appears to disclose intravesical electromotive administration of specified dye substances for localisation and treatment of occult bladder cancers. Innocuous dye substances provide differential staining of cancerous and normal urothelium; and anticancer dye substances demonstrate differential staining and also initiate therapy of cancerous lesions. The addition of vasodilating agents accentuate the differential staining and further promote therapy of the cancerous sites.
U.S. Patent Application Publication No. 2014/0056986 appears to disclose methods and compositions for treating bladder cancer, including metastatic bladder cancer and non-muscle-invasive bladder cancer, by administering a composition comprising nanoparticles that comprise a taxane (a diterpene and an albumin.
U.S. Patent Application Publication No. 2008/0119440 appears to disclose methods of treating a proliferative disease, such as cancer, with bis(thio-hydrazide amides) or a tautomer, pharmaceutically acceptable salt, solvate, clathrate, or prodrug thereof, in combination with hyperthermia treatment. The '440 reference also discloses treating a proliferative disease, such as cancer, with bis(thio-hydrazide amides) or a tautomer, pharmaceutically acceptable salt, solvate, clathrate, or prodrug thereof, in combination with radiotherapy.
U.S. Patent Application Publication No. 2008/0064047 appears to disclose that three proteins, Cystatin B, Chaperonin 10, and Profilin are present in the urine of patients with bladder cancer. Accordingly, the '047 reference discloses methods for prognostic evaluation of cancers of epithelial origin and to methods for facilitating diagnosis of cancers of epithelial origin by monitoring the presence of these markers in biological samples. The '047 reference is also directed to markers for therapeutic efficacy.
U.S. Patent Application Publication No. 2007/0161580 appears to disclose a method for treating cancer by blocking the migration, metastasis of cancer cells, growth of cancers wherein the cancers comprise breast cancer, leukocyte cancer, liver cancer, ovarian cancer, bladder cancer, prostate cancer, skin cancer, bone cancer, brain cancer, leukemia cancer, lung cancer, colon cancer, CNS cancer, melanoma cancer, renal cancer or cervix cancer. The '580 reference discloses the use of compositions comprising a triterpenoidal saponin, triterpenoid, triterpenoidal compound or sapongenin, having at least two side groups selected from the group consisting of angeloyl groups, tigloyl groups and senecioyl groups, wherein the side groups are attached to carbon 21, 22 or/and 28 of triterpenoidal sapogenin, triterpenoid, triterpenoidal compound or other sapongenin backbones.
U.S. Patent Application Publication No. 2005/0276872 appears to disclose compositions, methods and process of producing extracts and pure compounds from Xanthoceras sorbifolia. The extract comprises saponins and other constituents including alkaloids, coumarins, saccharides, proteins, polysaccharides, glycosides, tannins, acid, flavonoids and others. The '872 reference discloses compositions that are used for treating cancer and other conditions, such as arthritis, rheumatism, poor circulation, arteriosclerosis, Raynaud's syndrome, angina pectoris, cardiac disorder, coronary heart disease, headache, kidney disorder, and impotence; for improving cerebral functions; or for curing enuresis, frequent micturition, urinary incontinence, dementia, weak intelligence and Alzheimer's disease, autism, brain trauma, Parkinson's, cerebral dysfunctions, and treating arthritis, rheumatism, poor circulation, arteriosclerosis, Raynaud's syndrome, angina pectoris, cardiac disorder, headache, dizziness, kidney disorder. The '872 reference discloses compounds of oleanene triterpenoidal saponin in nature with the characteristics that at least one angeloyl group is attached to carbon 21 or/and 22, or/and is linked to the sugar.
U.S. Patent Application Publication No. 2004/0253265 appears to disclose pharmaceutical compositions and dietary supplements comprising yeast cells that can produce a healthful benefit in a subject inflicted with bladder cancer. The biological compositions can be used to retard the growth of bladder cancer cells and/or prolonging the time of survival of the subject.
U.S. Patent Application Publication No. 2002/0123465 appears to disclose TGF-α polypeptides, related polypeptides, fragments and mimetics thereof useful in stimulating stem cell or precursor cell proliferation, migration and differentiation. The '465 reference appears to disclose methods that are useful to treat tissue injury as well as expand stem cell populations in, or obtained from, gastrointestinal, musculoskeletal, urogenital, neurological and cardiovascular tissues. The methods include ex vivo and in vivo applications.
While the above-identified medical treatments, as disclosed hereinabove, appear to provide at least treatment to those with bladder cancer, such treatment remains non-desirous and/or problematic inasmuch as, among other things, none of the above-identified treatments provide sufficient results from the debilitating effects of bladder cancer without material drawbacks. As such, there remains a genuine demand for non-invasive and/or substantially non-invasive medical treatments that are effective and that remedy the detriments and/or complications associated with the above-identified remedies.
It is therefore an object of the present invention to provide a new, useful, and nonobvious method for treating bladder cancer.
These and other objects of the present invention will become apparent in light of the present specification, claims, and drawings.